Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day
Abstract Background In the phase 2 double‐blind Study 211, a starting dose of lenvatinib 18 mg/day was compared with the approved starting dose of 24 mg/day in patients with radioiodine‐refractory differentiated thyroid cancer (RR‐DTC). Predefined criteria for noninferiority for efficacy in the 18 m...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-02-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.5308 |
| _version_ | 1797893183224414208 |
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| author | Matthew H. Taylor Sophie Leboulleux Yury Panaseykin Bhavana Konda Christelle de LaFouchardiere Brett G. M. Hughes Andrew G. Gianoukakis Young Joo Park Ilia Romanov Monika K. Krzyzanowska Diana Garbinsky Bintu Sherif Jie Janice Pan Terri A. Binder Nicholas Sauter Ran Xie Marcia S. Brose |
| author_facet | Matthew H. Taylor Sophie Leboulleux Yury Panaseykin Bhavana Konda Christelle de LaFouchardiere Brett G. M. Hughes Andrew G. Gianoukakis Young Joo Park Ilia Romanov Monika K. Krzyzanowska Diana Garbinsky Bintu Sherif Jie Janice Pan Terri A. Binder Nicholas Sauter Ran Xie Marcia S. Brose |
| author_sort | Matthew H. Taylor |
| collection | DOAJ |
| description | Abstract Background In the phase 2 double‐blind Study 211, a starting dose of lenvatinib 18 mg/day was compared with the approved starting dose of 24 mg/day in patients with radioiodine‐refractory differentiated thyroid cancer (RR‐DTC). Predefined criteria for noninferiority for efficacy in the 18 mg arm were not met; safety was similar in both arms. Impact of lenvatinib treatment on health‐related quality‐of‐life (HRQoL) was a secondary endpoint of Study 211. Methods Patients with RR‐DTC were randomly assigned to a blinded starting dose of lenvatinib 18 mg/day or 24 mg/day. HRQoL was assessed at baseline, every 8 weeks until Week 24, then every 16 weeks, and at the off‐treatment visit, using the EQ‐5D‐3L and FACT‐G instruments. Completion and compliance rates, mean change from baseline, and times to first and definitive deterioration were evaluated. Results Baseline EQ‐5D and FACT‐G scores, and overall changes from baseline, were comparable between patients in the lenvatinib 18 mg/day (n = 77) and 24 mg/day arms (n = 75). For the 18 mg versus 24 mg arms, least squares mean differences were −0.42 (95% CI −4.88, 4.03) for EQ‐5D‐VAS and 0.47 (95% CI −3.45, 4.39) for FACT‐G total. Time to first deterioration did not significantly favor either arm; EQ‐5D‐VAS HR [18 mg/24 mg] 0.93 (95% CI 0.61–1.40), EQ‐5D‐HUI HR [18 mg/24 mg] 0.68 (95% CI 0.44–1.05), FACT‐G total HR [18 mg/24 mg] 0.73 (95% CI 0.48–1.12). Time to definitive deterioration did not significantly favor either arm, though EQ‐5D‐VAS showed a trend in favor of the 24 mg arm (HR [18 mg/24 mg] 1.72; 95% CI 0.99–3.01); EQ‐5D‐HUI HR [18 mg/24 mg] was 0.96 (95% CI 0.57–1.63), FACT‐G total HR [18 mg/24 mg] was 0.72 (95% CI 0.43–1.21). Conclusions In Study 211, HRQoL for patients in the lenvatinib 18 mg/day arm was not statistically different from that of patients in the 24 mg/day arm. These data further support the use of the approved lenvatinib starting dose of 24 mg/day in patients with RR‐DTC. ClinicalTrials.gov Number NCT02702388. |
| first_indexed | 2024-04-10T06:49:58Z |
| format | Article |
| id | doaj.art-dc0ec1a8bab345c086c5e789e1eef9a5 |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-04-10T06:49:58Z |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-dc0ec1a8bab345c086c5e789e1eef9a52023-02-28T08:51:57ZengWileyCancer Medicine2045-76342023-02-011244332434210.1002/cam4.5308Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/dayMatthew H. Taylor0Sophie Leboulleux1Yury Panaseykin2Bhavana Konda3Christelle de LaFouchardiere4Brett G. M. Hughes5Andrew G. Gianoukakis6Young Joo Park7Ilia Romanov8Monika K. Krzyzanowska9Diana Garbinsky10Bintu Sherif11Jie Janice Pan12Terri A. Binder13Nicholas Sauter14Ran Xie15Marcia S. Brose16Earle A. Chiles Research Institute, Providence Portland Medical Center Portland Oregon USADepartment of Nuclear Medicine and Endocrine Oncology Gustave Roussy and University Paris Saclay Villejuif FranceA. Tsyb Medical Radiological Research Center, branch of the NMRС of Radiology Obninsk Russian FederationDivision of Medical Oncology The Ohio State University Comprehensive Cancer Center Ohio Columbus USAMedical Oncology Department Centre Léon Bérard Lyon FranceDepartment of Cancer Care Services Royal Brisbane and Women's Hospital, University of Queensland Queensland AustraliaThe Lundquist Institute at Harbor‐UCLA Medical Center, David Geffen School of Medicine at UCLA California Los Angeles/Torrance USADepartment of Internal Medicine Seoul National University College of Medicine Seoul Republic of KoreaDepartment of Head & Neck Tumors N.N. Blokhin Russian Cancer Research Center Moscow Russian FederationDepartment of Medical Oncology & Hematology Princess Margaret Cancer Centre Ontario Toronto CanadaRTI Health Solutions Research Triangle Park North Carolina USARTI Health Solutions Research Triangle Park North Carolina USAGlobal Value and Access (GV&A) Oncology, Eisai Inc. New Jersey Nutley USAOncology Clinical Research Eisai Inc. New Jersey Nutley USAOncology Clinical Research Eisai Inc. New Jersey Nutley USABiostatistics, Eisai Inc. New Jersey Nutley USADepartment of Medical Oncology Sidney Kimmel Cancer Center, Jefferson University (previous affiliation: Department of Otorhinolaryngology: Head and Neck Surgery, Abramson Cancer Center, University of Pennsylvania) Pennsylvania Philadelphia USAAbstract Background In the phase 2 double‐blind Study 211, a starting dose of lenvatinib 18 mg/day was compared with the approved starting dose of 24 mg/day in patients with radioiodine‐refractory differentiated thyroid cancer (RR‐DTC). Predefined criteria for noninferiority for efficacy in the 18 mg arm were not met; safety was similar in both arms. Impact of lenvatinib treatment on health‐related quality‐of‐life (HRQoL) was a secondary endpoint of Study 211. Methods Patients with RR‐DTC were randomly assigned to a blinded starting dose of lenvatinib 18 mg/day or 24 mg/day. HRQoL was assessed at baseline, every 8 weeks until Week 24, then every 16 weeks, and at the off‐treatment visit, using the EQ‐5D‐3L and FACT‐G instruments. Completion and compliance rates, mean change from baseline, and times to first and definitive deterioration were evaluated. Results Baseline EQ‐5D and FACT‐G scores, and overall changes from baseline, were comparable between patients in the lenvatinib 18 mg/day (n = 77) and 24 mg/day arms (n = 75). For the 18 mg versus 24 mg arms, least squares mean differences were −0.42 (95% CI −4.88, 4.03) for EQ‐5D‐VAS and 0.47 (95% CI −3.45, 4.39) for FACT‐G total. Time to first deterioration did not significantly favor either arm; EQ‐5D‐VAS HR [18 mg/24 mg] 0.93 (95% CI 0.61–1.40), EQ‐5D‐HUI HR [18 mg/24 mg] 0.68 (95% CI 0.44–1.05), FACT‐G total HR [18 mg/24 mg] 0.73 (95% CI 0.48–1.12). Time to definitive deterioration did not significantly favor either arm, though EQ‐5D‐VAS showed a trend in favor of the 24 mg arm (HR [18 mg/24 mg] 1.72; 95% CI 0.99–3.01); EQ‐5D‐HUI HR [18 mg/24 mg] was 0.96 (95% CI 0.57–1.63), FACT‐G total HR [18 mg/24 mg] was 0.72 (95% CI 0.43–1.21). Conclusions In Study 211, HRQoL for patients in the lenvatinib 18 mg/day arm was not statistically different from that of patients in the 24 mg/day arm. These data further support the use of the approved lenvatinib starting dose of 24 mg/day in patients with RR‐DTC. ClinicalTrials.gov Number NCT02702388.https://doi.org/10.1002/cam4.5308dose intensityHRQoLkinase inhibitorlenvatinibquality of liferadioiodine‐refractory differentiated thyroid cancer |
| spellingShingle | Matthew H. Taylor Sophie Leboulleux Yury Panaseykin Bhavana Konda Christelle de LaFouchardiere Brett G. M. Hughes Andrew G. Gianoukakis Young Joo Park Ilia Romanov Monika K. Krzyzanowska Diana Garbinsky Bintu Sherif Jie Janice Pan Terri A. Binder Nicholas Sauter Ran Xie Marcia S. Brose Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day Cancer Medicine dose intensity HRQoL kinase inhibitor lenvatinib quality of life radioiodine‐refractory differentiated thyroid cancer |
| title | Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day |
| title_full | Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day |
| title_fullStr | Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day |
| title_full_unstemmed | Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day |
| title_short | Health‐related quality‐of‐life analyses from a multicenter, randomized, double‐blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day |
| title_sort | health related quality of life analyses from a multicenter randomized double blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg day |
| topic | dose intensity HRQoL kinase inhibitor lenvatinib quality of life radioiodine‐refractory differentiated thyroid cancer |
| url | https://doi.org/10.1002/cam4.5308 |
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